Low-Dose Dexmedetomidine for Postoperative Pain in Scoliosis

Overseen By Julia Leamon, MSN, RN, CPN

Age: < 65

Sex: Any

Trial Phase: Phase 4

Sponsor: Children's Mercy Hospital Kansas City

Must not be taking: Opioids, TCA's, Gabapentinoids, Digoxin

Disqualifiers: Chronic pain, Unstable cardiac, Moya Moya, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 48

Duration: 2 days

160 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are currently taking opioids, TCAs (tricyclic antidepressants), or gabapentinoids for chronic pain, you would not be eligible to participate.

What data supports the effectiveness of the drug Dexmedetomidine (Precedex) for postoperative pain in scoliosis surgery?

Research shows that dexmedetomidine can reduce the need for opioids and improve pain management after major spine surgeries, including scoliosis correction. It has been effective in decreasing opioid use in children with scoliosis and improving pain scores in adult spine surgeries. ^{1 2 3 4 5}

Is dexmedetomidine generally safe for use in humans?

Dexmedetomidine (Precedex) is generally considered safe and is frequently used as a sedative during surgeries, but it can cause side effects like respiratory depression (slowed breathing) and hypotension (low blood pressure). There was a case of cardiac arrest in a patient with a pacemaker, so caution is advised in certain situations. In pediatric studies, it was well-tolerated, though some adverse events like bradycardia (slow heart rate) and hypotension were reported. ^{1 4 6 7 8}

How does the drug dexmedetomidine differ from other treatments for postoperative pain in scoliosis?

Dexmedetomidine is unique because it is used in low doses to manage postoperative pain, potentially reducing the need for stronger pain medications like opioids, which can have more side effects. It is also used during scoliosis surgery to help with sedation and pain control, making it a versatile option for both intraoperative and postoperative care. ^{1 4 5 9 10}

What is the purpose of this trial?

This randomized controlled trial examines whether the addition of a low-dose dexmedetomidine infusion to our current multimodal pain management plan decreases narcotic consumption and reduces side effects in adolescent patients undergoing posterior spinal fusion for idiopathic scoliosis.

Research Team

Nichole M Doyle, MD

Principal Investigator

Children's Mercy Hospital Kansas City

Eligibility Criteria

This trial is for adolescents with idiopathic scoliosis who are having a spinal fusion surgery involving at least five levels of both thoracic and lumbar spine. It's not open to those who don't meet these specific surgical and diagnostic criteria.

Inclusion Criteria

I am having a spine surgery that involves both my upper and lower back.

I have been diagnosed with idiopathic scoliosis.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a low dose dexmedetomidine infusion or a normal saline infusion for 48 hours post-operatively

2 days

In-hospital stay

Follow-up

Participants are monitored for safety and effectiveness after treatment, including pain scores and side effects

48 hours

Questionnaire every 48 hours

Treatment Details

Interventions

• Dexmedetomidine

Trial Overview The study is testing if low-dose dexmedetomidine added to standard pain management after surgery can reduce the need for narcotics and lessen side effects in teens with scoliosis undergoing spinal fusion.

Participant Groups

Group I: Dexmedetomidine Experimental Treatment 1 Intervention

Patient receives low dose dexmedetomidine infusion in addition to normal post-operative pain management protocol

Group II: Control Placebo Group 1 Intervention

Patient receives normal saline infusion in addition to normal post-operative pain management protocol

Who Is Running the Clinical Trial?

Children's Mercy Hospital Kansas City

Lead Sponsor

Trials

261

Recruited

941,000+

Findings from Research

A mini-dose combination of esketamine and dexmedetomidine significantly reduced the incidence of moderate-to-severe pain after scoliosis correction surgery, with 65.7% of patients experiencing pain compared to 86.0% in the placebo group.

Patients receiving the combination treatment also reported better sleep quality and lower pain intensity both at rest and during movement, without an increase in adverse events, indicating a safe and effective analgesic strategy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mini-dose esketamine-dexmedetomidine combination to supplement analgesia for patients after scoliosis correction surgery: a double-blind randomised trial. Zhang, Y., Cui, F., Ma, JH., et al.[2023]

Dexmedetomidine is gaining popularity in pediatric care due to its strong safety and efficacy profile, particularly as an alternative to morphine for pain management in surgeries like craniosynostosis repair.

This study is the first to specifically evaluate the use of dexmedetomidine as a postoperative analgesic and sedative in children after craniosynostosis repair, highlighting a gap in existing research on its application in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Precedex in Post-Operative Pain Management Following Craniosynostosis Repair. Xu, H., Bui, A., Brown, S., et al.[2021]

In a case study of a 16-year-old girl undergoing scoliosis surgery, the use of dexmedetomidine in combination with total intravenous anesthesia provided effective sedation and analgesia during the critical wake-up test, allowing for safe assessment of lower limb movement.

The patient successfully regained spontaneous ventilation and was able to move her lower limbs upon command 14 minutes after the withdrawal of propofol and remifentanil, demonstrating the efficacy of dexmedetomidine in maintaining sedation while ensuring patient safety during the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Dexmedetomidine as adjuvant drug for wake-up test during scoliosis correction surgery: case report.]. Bagatini, A., Volquind, D., Rosso, A., et al.[2022]

Dexmedetomidine is commonly used as a safe sedative during surgeries, but there are rare cases where it can lead to serious complications, such as cardiac arrest.

In this report, a 76-year-old woman experienced cardiac arrest during a pacemaker lead extraction procedure while being treated with dexmedetomidine, highlighting the need for careful monitoring in older patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dexmedetomidine related cardiac arrest in a patient with permanent pacemaker; a cautionary tale. Shah, AN., Koneru, J., Nicoara, A., et al.[2013]

In a study of 24 pediatric patients undergoing airway reconstruction, dexmedetomidine was found to be well tolerated and safe, particularly for short-term intubation, with no significant adverse effects reported.

Dexmedetomidine may serve as a beneficial alternative to propofol for sedation during the periextubation period, allowing for easily reversible sedation, although further research is needed to explore its long-term safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dexmedetomidine use in pediatric airway reconstruction. Silver, AL., Yager, P., Purohit, P., et al.[2022]

In a study involving 91 pediatric patients, dexmedetomidine was found to be a well-tolerated alternative sedative for non-intubated moderate or deep sedation, with a low incidence of serious adverse events.

While respiratory depression and hypotension were the most common treatment-emergent adverse events, they were manageable and consistent with dexmedetomidine's known safety profile, indicating its potential for safe use in children during elective procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase IV, Open-Label, Safety Study Evaluating the Use of Dexmedetomidine in Pediatric Patients Undergoing Procedure-Type Sedation. Jooste, EH., Hammer, GB., Reyes, CR., et al.[2020]

In a study of 60 ASA III patients undergoing spinal orthopedic scoliosis correction surgery, dexmedetomidine at doses of 0.2 to 0.3 μg/(kg·h) resulted in shorter wake-up times and fewer hemodynamic fluctuations compared to a higher dose of 0.4 μg/(kg·h).

Group B (0.3 μg/(kg·h)) showed significantly higher mean arterial pressure just before and at the moment of wake-up compared to Group A (0.2 μg/(kg·h)), indicating better hemodynamic stability with this dosage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dexmedetomidine dosage in critically ill patients undergoing intraoperative wake-up test: A randomized controlled trial. Yang, T., Mudabbar, MS., Chen, T., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Mini-dose esketamine-dexmedetomidine combination to supplement analgesia for patients after scoliosis correction surgery: a double-blind randomised trial. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

The Effect of Dexmedetomidine on Postoperative Opioid Consumption and Pain After Major Spine Surgery. [2016]

3. United States pubmed.ncbi.nlm.nih.gov

Evaluation of dexmedetomidine and postoperative pain management in patients with adolescent idiopathic scoliosis: conclusions based on a retrospective study at a tertiary pediatric hospital. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

The Role of Precedex in Post-Operative Pain Management Following Craniosynostosis Repair. [2021]

5. Brazil pubmed.ncbi.nlm.nih.gov

[Dexmedetomidine as adjuvant drug for wake-up test during scoliosis correction surgery: case report.]. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Dexmedetomidine related cardiac arrest in a patient with permanent pacemaker; a cautionary tale. [2013]

7. England pubmed.ncbi.nlm.nih.gov

Dexmedetomidine use in pediatric airway reconstruction. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Phase IV, Open-Label, Safety Study Evaluating the Use of Dexmedetomidine in Pediatric Patients Undergoing Procedure-Type Sedation. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Dexmedetomidine dosage in critically ill patients undergoing intraoperative wake-up test: A randomized controlled trial. [2022]

10. Greece pubmed.ncbi.nlm.nih.gov

Efficacy of dexmedetomidine in reducing post-operative pain and improving the quality of recovery in patients with burn wounds undergoing tangential excision skin grafting. [2020]